Seqens Seqens

X
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million","upfrontCash":"Undisclosed","newsHeadline":"CytoDyn Highlights NIH Grant for HIV Functional Cure Preclinical Study of Gene Therapy Based on Leronlimab","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Preclinical"},{"orgOrder":0,"company":"CytoDyn","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CytoDyn Announces Voluntary Withdrawal of BLA for HIV-MDR Due to CRO Data Management Issues","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"CytoDyn","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CytoDyn Announces Submission of Clinical Protocol to FDA and Initiation of Pre-Clinical Study in Glioblastoma","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"CytoDyn","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CytoDyn Announces FDA Has Lifted Clinical Hold","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II\/ Phase III"}]

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            PRO 140 (leronlimab) is a CCR5 antagonist with the potential for multiple therapeutic indications. It is being evaluated for the treatment of HIV infection.

            Lead Product(s): Leronlimab

            Therapeutic Area: Infections and Infectious Diseases Product Name: PRO 140

            Highest Development Status: Phase II/ Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 29, 2024

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            PRO 140 (leronlimab) is a CCR5 antagonist with the potential for multiple therapeutic indications. It is being evaluated in phase 2 clinical trials for the treatment of HIV infection.

            Lead Product(s): Leronlimab

            Therapeutic Area: Infections and Infectious Diseases Product Name: PRO 140

            Highest Development Status: Phase II/ Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 01, 2024

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            PRO 140 (leronlimab) is an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes.

            Lead Product(s): Leronlimab

            Therapeutic Area: Infections and Infectious Diseases Product Name: PRO 140

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 28, 2022

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            The grant will fund the development and preclinical research of a single-injection gene therapy that codes for the leronlimab protein sequence and which will be delivered via an adeno-associated virus (AAV) vector.

            Lead Product(s): AAV-based Gene Therapy

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Preclinical Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Oregon Health & Science University

            Deal Size: $5.0 million Upfront Cash: Undisclosed

            Deal Type: Funding July 11, 2022

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            Leronlimab treatment reduced SHIV viral loads by 10,000 fold and leronlimab was found within all anatomical compartments analyzed, including mucosal and lymphatic tissues, sites of early viral replication after transmission and latency.

            Lead Product(s): Leronlimab

            Therapeutic Area: Infections and Infectious Diseases Product Name: PRO 140

            Highest Development Status: Phase II/ Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 12, 2022

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            Leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes.

            Lead Product(s): Leronlimab

            Therapeutic Area: Infections and Infectious Diseases Product Name: PRO 140

            Highest Development Status: Phase II/ Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 30, 2022

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            The trial was conducted in two parts for PRO 140 (Leronlimab), Part 1 compared a 700 mg weekly dose and Part 2 evaluated a 350 mg weekly dose, positive result is obtained from the 350 mg weekly dose for Phase 2 NASH clinical trial.

            Lead Product(s): Leronlimab

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: PRO 140

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 05, 2022

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            During recent discussions with the FDA, the agency suggested that developing Vyrologix (leronlimab) for critically ill COVID-19 patients in current situation in U.S. appears feasible.

            Lead Product(s): Leronlimab

            Therapeutic Area: Infections and Infectious Diseases Product Name: Vyrologix

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 09, 2021

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            Phase 3 pivotal trial yielded a statistically significant primary endpoint for efficacy (p=0.0032), had an 81% success rate in suppressing viral load (VL<50 cp/mL) in the MDR population after 24 weeks of Vyrologix (leronlimab) treatment.

            Lead Product(s): Leronlimab

            Therapeutic Area: Infections and Infectious Diseases Product Name: Vyrologix

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 09, 2021

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            Company developing Vyrologix (leronlimab), a CCR5 antagonist announced that its CRO in Brazil met with ANVISA to modify the CD16 trial for critically ill COVID-19 patients.

            Lead Product(s): Leronlimab

            Therapeutic Area: Infections and Infectious Diseases Product Name: Vyrologix

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 08, 2021

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